COMUNICATO - Modifica dell'autorizzazione all'immissione in commercio del medicinale per uso umano «Levofloxacina Actavis» (15A03280)
Estratto determina V&A/748 del 14 aprile 2015 Autorizzazione della variazione: A Altre variazioni. Relativamente al medicinale: LEVOFLOXACINA ACTAVIS. Numero procedura europea: EE/H/0132/001-002/II/008. Titolare A.I.C.: Actavis Group PTC EHF. E' autorizzata la seguente variazione: introduzione del nuovo produttore di sostanza attiva Levofloxacina Emidrato Teva Pharmaceutical Industries Ltd (sito di produzione: Teva-Tech site, Ramat Hovav Emek Sara, P.O. Box 2049 Beer Sheva 84874, Israel), in possesso del DMF 4454- EU11.2013, relativamente alle confezioni autorizzate all'immissione in commercio in Italia a seguito di procedura...
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